Sr Associate, QA Compliance & System

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ppAlfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. /p pOver three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities. /p pBut our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets. /p h3Scope of the Role /h3 pThe Quality Compliance Specialist, reporting directly to the Quality Compliance Coordinator, will be part of a team of three people and will play a key role in the management and continuous improvement of the electronic Quality Management System (eQMS). The role focuses on ensuring the effective management of training records, document control, procedural workflows, and the CAPA system, while maintaining full compliance with GMP requirements and internal Quality System standards. Working closely with Quality Assurance and other internal and external stakeholders, the position contributes to strengthening the company’s quality culture and ensuring regulatory compliance across the organization. /p h3Your Role /h3 pIn this role, you will support the implementation, maintenance,



and continuous improvement of the Quality Management System, with a strong focus on training compliance, CAPA management, and document control processes. Main Responsibilities: /p pManage the training process within the eQMS, ensuring accurate maintenance of training records and compliance with regulatory requirements. /p pIdentify and assess training needs across departments. /p pPrepare, deliver, and monitor training materials and programs, including GMP and compliance‑related topics. /p pEvaluate the effectiveness of training programs and implement improvements where necessary. /p pAct as a GMP subject matter expert and support the continuous improvement of training effectiveness. /p pMentor and support colleagues, fostering a strong quality and compliance culture. /p pOversee the CAPA (Corrective and Preventive Actions) process, including tracking, follow‑up, effectiveness checks, and timely closure. /p pParticipate in or lead CAPA‑related projects, ensuring compliance, quality, and adherence to deadlines. /p pCompile, analyze, and report performance metrics related to CAPAs, Change Controls, and other Quality System activities. /p pSupport continuous improvement initiatives within the Quality Management System. /p pManage and maintain document control processes within the eQMS. /p pSupport the issuance, revision, and periodic review of Standard Operating Procedures (SOPs),



ensuring alignment with regulatory and corporate standards. /p pEnsure procedural workflows are up to date and compliant with GMP requirements. /p pAdminister and monitor Quality Agreements with external partners, ensuring alignment with regulatory and corporate standards. /p pSupport external audits by providing documentation, data analysis, and process insights as required. /p h3Who You Are /h3 pDegree in Life Sciences, Pharmacy, Chemistry, or a related scientific discipline. /p pAt least 3 years of experience in Quality Assurance or Quality Compliance within the pharmaceutical industry. /p pStrong knowledge of GMP requirements and regulatory expectations. /p pExperience working with electronic Quality Management Systems (eQMS). /p pSolid understanding of SOP management, Quality Agreements, and CAPA processes. /p pStrong organizational skills, attention to detail, and ability to manage multiple priorities. /p pExcellent communication skills and ability to work effectively in a cross‑functional environment. /p pGood command of English, both written and spoken. /p h3Why Join Alfasigma /h3 pAt Alfasigma, we foster a culture where the courage to innovate is key to our success. We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. /p pOur commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open‑mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. /p pbJoin Alfasigma and become part of a forward‑thinking team dedicated to shaping the future of the pharmaceutical industry. /b /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b84b3